Biomedical manufacturers and their suppliers rely on an effective quality management system to ensure they produce safe and effective products, and comply with numerous regulatory requirements.  Despite the critical importance of the quality management system, many of those working for these types of companies have had little or no formal training.  Or, training only focuses on presenting what the regulations and standard state, without really explaining their intent.  This class fills that gap by explaining what a quality system is and what its real intent is, the history of the regulations that define the requirements, what those requirements are, and what they really mean.  This class will be particularly beneficial for those who typically only get to work within a small part of their company’s quality management system.  However, those who have been in the industry for a long time in many roles, may also be surprised by what they hear and learn in this class as the instructor provides a clearer view of the entire system.

Topics to be covered in this two half-day workshop are:

• History of Quality, Standards, Regulations, and the FDA
  • How did we get here?
• Quality System Basic Concepts & Intents
  • What is Quality and why is it a system?
• Management Responsibility
  • Why does leadership matter to quality?
• Resource Management
  • Are training and competency the same thing?
  • BTW, there are other resources to manage besides humans
• Documents & Records
  • What’s the difference and how do you produce good ones?
• Control of Nonconforming Product
  • “Product” may not mean what you think it does.
• Customer Feedback
  • Not all feedback is a complaint?
• Audits
  • What are internal audits supposed to be for, and what happens in an external audit?
• CAPA
  • Why is this so important and why do manufacturers keep getting it wrong?
• Design Control
  • What is it and when does it really begin?
• Design Transfer
  • What is it and when does it really begin?

Date:  Wednesday, February 9th & Thursday February 10th

Time:  8:00 am CST - 12:00 PM CST each day

Cost:  ASQ Members $50 / Non-Members $75

Location: This is a hybrid (Zoom) and on-site at St. Cloud State in Plymouth Event

           9750 Rockford Rd, Plymouth, MN 55442

** If after registering you wish to change your location, please email Karen Peifer at [email protected] to do so **
 

Certificate of Completion:  Issued on workshop completion for 0.6 ASQ RUs or 0.6 CEUs.

Instructor Bio:  

Steve Gompertz (CQM, CBA, RAC-US, CMII) is a leader in Quality Systems management with over 25 years of experience in the life-science industry.  His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data.  He is now a consultant to the industry providing guidance on quality systems and regulatory compliance.

Steve holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality- related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in M.S. in its Medical Technology Quality program.